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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR HOLLOW FIBER OXYGENATOR/RESERVOIR, MEMBRANE OXYGENATOR

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SORIN GROUP ITALIA S.R.L. LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR HOLLOW FIBER OXYGENATOR/RESERVOIR, MEMBRANE OXYGENATOR Back to Search Results
Model Number D902
Device Problems Fluid Leak (1250); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2017
Event Type  malfunction  
Manufacturer Narrative
Patient identifier was not provided. Patient sex was not provided. Patient weight was not provided. The age of the device was calculated as the time elapsed between device sterilization and the date of the event. (b)(4). (b)(4) manufactures the d902 dideco lilliput 2 infant hollow fiber oxygenator. The incident occurred in (b)(6). (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. No other similar complaints have been recorded on this device in the past three years. The involved device is not available for return to sorin group (b)(4) for investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not available to be returned.
 
Event Description
Sorin group (b)(4) received a report that a blood to water leakage occurred in a lilliput 2 infant hollow fiber oxygenator during a procedure. A new oxygenator could not be primed due to the unavailability of blood so the patient temperature was recovered using a heater cooler and blanket. This reportedly took 2 hours. There was no report of patient injury.
 
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Brand NameLILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
Type of DeviceHOLLOW FIBER OXYGENATOR/RESERVOIR, MEMBRANE OXYGENATOR
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola 41037
IT 41037
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola (mo) 41037
IT 41037
Manufacturer Contact
joan caesar
14401 w 65th way
arvada, CO 80004
2812287260
MDR Report Key6816109
MDR Text Key83627786
Report Number9680841-2017-00023
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K971877
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 08/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/10/2019
Device Model NumberD902
Device Catalogue Number05324
Device Lot Number1602100009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/20/2017
Device Age17 MO
Event Location No Information
Date Manufacturer Received07/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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